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3. Ondansetron for irritable bowel syndrome with diarrhoea: randomised controlled trial

Author

Gunn, David, primary, Topan, Rabia, additional, Fried, Ron, additional, Holloway, Ivana, additional, Brindle, Richard, additional, Hartley, Suzanne, additional, Barnard, Lorna, additional, Corsetti, Maura, additional, Scott, S Mark, additional, Farmer, Adam, additional, Akbar, Ayesha, additional, Eugenicos, Maria, additional, Trudgill, Nigel, additional, Kapur, Kapil, additional, McLaughlin, John, additional, Sanders, David S, additional, Ramadas, Arvind, additional, Whorwell, Peter, additional, Houghton, Lesley, additional, Dinning, Phil G, additional, Aziz, Qasim, additional, Ford, Alexander C, additional, Farrin, Amanda, additional, and Spiller, Robin, additional

Published
2023
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4. An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Holmes, Jain, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Published
2020
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5. RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations

Author

Airlie, Jennifer, primary, Burton, Louisa-Jane, additional, Copsey, Bethan, additional, English, Coralie, additional, Farrin, Amanda, additional, Fitzsimons, Claire F, additional, Holloway, Ivana, additional, Horrocks, Judith, additional, Johansson, Jessica Faye, additional, Mead, Gillian, additional, Moreau, Lauren A, additional, Ozer, Seline, additional, Patel, Anita, additional, Yaziji, Nahel, additional, and Forster, Anne, additional

Published
2023
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6. A Multidimensional Approach to Assessing Factors Impacting Health-Related Quality of Life after Pediatric Traumatic Brain Injury

Author

von Steinbuechel, Nicole, primary, Krenz, Ugne, additional, Bockhop, Fabian, additional, Koerte, Inga K., additional, Timmermann, Dagmar, additional, Cunitz, Katrin, additional, Zeldovich, Marina, additional, Andelic, Nada, additional, Rojczyk, Philine, additional, Bonfert, Michaela Veronika, additional, Berweck, Steffen, additional, Kieslich, Matthias, additional, Brockmann, Knut, additional, Roediger, Maike, additional, Lendt, Michael, additional, Buchheim, Anna, additional, Muehlan, Holger, additional, Holloway, Ivana, additional, and Olabarrieta-Landa, Laiene, additional

Published
2023
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7. Health-Related Quality of Life after Pediatric Traumatic Brain Injury: A Quantitative Comparison between Children's and Parents' Perspectives of the QOLIBRI-KID/ADO Questionnaire.

Author

Cunitz, Katrin, Holloway, Ivana, Harzendorf, Anne, Greving, Sven, Zeldovich, Marina, Krenz, Ugne, Timmermann, Dagmar, Koerte, Inga K., Bonfert, Michaela Veronika, Berweck, Steffen, Kieslich, Matthias, Brockmann, Knut, Roediger, Maike, Buchheim, Anna, Andelic, Nada, Lendt, Michael, Staebler, Michael, Muehlan, Holger, and von Steinbuechel, Nicole

Subjects
*PARENT attitudes, *QUALITY of life, *BRAIN injuries, *SUBJECTIVE well-being (Psychology), *INTRACLASS correlation
Abstract

Pediatric health-related quality of life (HRQoL) as a measure of subjective wellbeing and functioning has received increasing attention over the past decade. HRQoL in children and adolescents following pediatric traumatic brain injury (pTBI) has been poorly studied, and performing adequate measurements in this population is challenging. This study compares child/adolescent and parent reports of HRQoL following pTBI using the newly developed Quality of Life after Brain Injury in Children and Adolescents (QOLIBRI-KID/ADO) questionnaire. Three hundred dyads of 8–17-year-old children/adolescents and their parents were included in the study. The parent–child agreement, estimated using intraclass correlation coefficients and Cohen's κ, displayed poor to moderate concordance. Approximately two-fifths of parents (39.3%) tended to report lower HRQoL for their children/adolescents on the total QOLIBRI-KID/ADO score. At the same time, about one-fifth (21.3%) reported higher HRQoL Total scores for their children/adolescents. The best agreement for parents rating adolescents (aged 13–17 years) was found in terms of the Total score and the Cognition and Self scale scores. To date, parent-reported HRQoL has been the preferred choice in pediatric research after TBI. However, with a parent–child disagreement of approximately 60%, our results highlight the importance of considering self-reports for children/adolescents capable of answering or completing the HRQoL measures. [ABSTRACT FROM AUTHOR]

Published
2023
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8. Randomised, placebo‐controlled trial and meta‐analysis show benefit of ondansetron for irritable bowel syndrome with diarrhoea: The TRITON trial

Author

Gunn, David, primary, Topan, Rabia, additional, Barnard, Lorna, additional, Fried, Ron, additional, Holloway, Ivana, additional, Brindle, Richard, additional, Corsetti, Maura, additional, Scott, Mark, additional, Farmer, Adam, additional, Kapur, Kapil, additional, Sanders, David, additional, Eugenicos, Maria, additional, Trudgill, Nigel, additional, Whorwell, Peter, additional, Mclaughlin, John, additional, Akbar, Ayesha, additional, Houghton, Lesley, additional, Dinning, Phil G., additional, Aziz, Qasim, additional, Ford, Alexander C., additional, Farrin, Amanda J., additional, and Spiller, Robin, additional

Published
2023
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9. Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial

Author

Gunn, David, Fried, Ron, Lalani, Rabia, Farrin, Amanda, Holloway, Ivana, Morris, Tom, Olivier, Catherine, Kearns, Rachael, Corsetti, Maura, Scott, Mark, Farmer, Adam, Emmanuel, Anton, Whorwell, Peter, Yiannakou, Yan, Sanders, David, Mclaughlin, John, Kapur, Kapil, Eugenicos, Maria, Akbar, Ayesha, Trudgill, Nigel, Houghton, Lesley, Dinning, Phil G., Ford, Alexander C., Aziz, Qasim, and Spiller, Robin

Published
2019
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10. An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Author

Forster, Anne, Hartley, Suzanne, Barnard, Lorna, Ozer, Seline, Hardicre, Natasha, Crocker, Tom, Fletcher, Marie, Moreau, Lauren, Atkinson, Ross, Hulme, Claire, Holloway, Ivana, Schmitt, Laetitia, House, Allan, Hewison, Jenny, Richardson, Gillian, Farrin, Amanda, and on behalf of the LoTS2Care Programme Management Group

Published
2018
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12. RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory

Author

Radford, Kathryn A, McKevitt, Christopher, Clarke, Sara, Powers, Katie, Phillips, Julie, Craven, Kristelle, Watkins, Caroline Leigh, Farrin, Amanda, Holmes, Jain, Cripps, Rachel, McLellan, Vicki, Sach, Tracey, Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O'Connor, Rory J, Stevens, Judith, Walker, Marion, Murray, John, Shone, Angela, Clarke, David, Radford, Kathryn A, McKevitt, Christopher, Clarke, Sara, Powers, Katie, Phillips, Julie, Craven, Kristelle, Watkins, Caroline Leigh, Farrin, Amanda, Holmes, Jain, Cripps, Rachel, McLellan, Vicki, Sach, Tracey, Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O'Connor, Rory J, Stevens, Judith, Walker, Marion, Murray, John, Shone, Angela, and Clarke, David

Abstract

Objectives: This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation. Setting: RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation. Participants and outcome measures: Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists’ attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descrip

Published
2022

13. Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot

Author

Moreau, Lauren A, primary, Holloway, Ivana, additional, Fylan, Beth, additional, Hartley, Suzanne, additional, Cundill, Bonnie, additional, Fergusson, Alison, additional, Alderson, Sarah, additional, Alldred, David Phillip, additional, Bojke, Chris, additional, Breen, Liz, additional, Ismail, Hanif, additional, Gardner, Peter, additional, Mason, Ellen, additional, Powell, Catherine, additional, Silcock, Jonathan, additional, Taylor, Andrew, additional, Farrin, Amanda, additional, and Gale, Chris, additional

Published
2022
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14. RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory

Author

Radford, Kathryn A, primary, McKevitt, Christopher, additional, Clarke, Sara, additional, Powers, Katie, additional, Phillips, Julie, additional, Craven, Kristelle, additional, Watkins, Caroline, additional, Farrin, Amanda, additional, Holmes, Jain, additional, Cripps, Rachel, additional, McLellan, Vicki, additional, Sach, Tracey, additional, Brindle, Richard, additional, Holloway, Ivana, additional, Hartley, Suzanne, additional, Bowen, Audrey, additional, O'Connor, Rory J, additional, Stevens, Judith, additional, Walker, Marion, additional, Murray, John, additional, Shone, Angela, additional, and Clarke, David, additional

Published
2022
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17. A systematic review and meta-analysis of non-workplace interventions to reduce time spend in sedentary in adults

Author

Hall, Jessica Faye, Corepal, Rekesh, Crocker, Thomas F, Lam, Natalie, Burton, Louisa-Jane, Birch, Karen, Carter, Gill, Clarke, David J, English, Coralie, Farrin, Amanda J, Fitzsimons, Claire, Hall, Jennifer, Holloway, Ivana, Ozer, Seline, Lawton, Rebecca, Mead, Gillian, Morton, Sarah, Patel, Anita, and Forster, Anne

Abstract

Background Sedentary behaviour has been the focus of considerable clinical, policy and research interest due to its detrimental effects on health and wellbeing. This systematic review aims to (1) develop a more precise description of different categories of interventions that aim to reduce sedentary time in adults by identifying specific components that form an intervention; (2) explore the effect of different categories of interventions in reducing time spent sedentary in adults.Methods Ten electronic databases, websites of relevant organisations (e.g. the Sedentary Behaviour Research Network), and relevant reviews were searched. Inclusion criteria: Randomised controlled trials (RCTs), including cluster and randomised cross-over trials, in the adult population (clinical and non-clinical). Any study including a measure of sedentary behaviour was included even if reducing sedentary behaviour was not the primary aim. Exclusion criteria: Interventions delivered in schools, colleges, or workplaces; studies investigating the immediate effects of breaking up sitting time as part of a supervised (usually laboratory-based) intervention. Two review authors conducted data extraction and quality assessment (GRADE approach).Results Searches identified 39,223 records, of which 85 studies met the inclusion criteria and were included in the review. Interventions shown to significantly reduce time spent sedentary were those which incorporated the provision of information, education, or support (advice/recommendations), in conjunction with either counselling (mean difference: -52.24 minutes/day; 95% CI: -85.37 to -19.10) or a form of structured/prescribed physical activity (standardised mean difference: -0.15; 95% CI: -0.23 to -0.07). However, this positive effect was not maintained at follow-up. No interventions were shown to break up prolonged sitting.Conclusions This review presents a novel way of categorising interventions according to the types of components they comprised. There is evidence that interventions might be effective in reducing time spent sedentary immediately post-intervention. There were limited studies measuring sustained behaviour change.

Published
2021

18. An international, multicentre, prospective, randomised, controlled, unblinded, parallel-group trial of robotic-assisted versus standard laparoscopic surgery for the curative treatment of rectal cancer

Author

Collinson, Fiona J., Jayne, David G., Pigazzi, Alessio, Tsang, Charles, Barrie, Jennifer M., Edlin, Richard, Garbett, Christopher, Guillou, Pierre, Holloway, Ivana, Howard, Helen, Marshall, Helen, McCabe, Christopher, Pavitt, Sue, Quirke, Phil, Rivers, Carly S., and Brown, Julia M. B.

Published
2012
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19. A systematic review and meta-analysis of non-workplace interventions to reduce time spent sedentary in adults

Author

Hall, Jessica Faye, primary, Corepal, Rekesh, additional, Crocker, Thomas F, additional, Lam, Natalie, additional, Burton, Louisa-Jane, additional, Birch, Karen, additional, Carter, Gill, additional, Clarke, David J, additional, English, Coralie, additional, Farrin, Amanda J, additional, Fitzsimons, Claire, additional, Hall, Jennifer, additional, Holloway, Ivana, additional, Ozer, Seline, additional, Lawton, Rebecca, additional, Mead, Gillian, additional, Morton, Sarah, additional, Patel, Anita, additional, and Forster, Anne, additional

Published
2021
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20. Longer-term health and social care strategies for stroke survivors and their carers: the LoTS2Care research programme including cluster feasibility RCT

Author

Forster, Anne, primary, Ozer, Seline, additional, Crocker, Thomas F, additional, House, Allan, additional, Hewison, Jenny, additional, Roberts, Elaine, additional, Dickerson, Josie, additional, Carter, Gill, additional, Hulme, Claire, additional, Fay, Matthew, additional, Richardson, Gillian, additional, Wright, Alan, additional, McKevitt, Christopher, additional, McEachan, Rosemary, additional, Foy, Robbie, additional, Barnard, Lorna, additional, Moreau, Lauren, additional, Prashar, Arvin, additional, Clarke, David, additional, Hardicre, Natasha, additional, Holloway, Ivana, additional, Brindle, Richard, additional, Hall, Jessica, additional, Burton, Louisa-Jane, additional, Atkinson, Ross, additional, Hawkins, Rebecca J, additional, Brown, Lesley, additional, Cornwall, Nicola, additional, Dawkins, Bryony, additional, Meads, David, additional, Schmitt, Laetitia, additional, Fletcher, Marie, additional, Speed, Michael, additional, Grenfell, Katie, additional, Hartley, Suzanne, additional, Young, John, additional, and Farrin, Amanda, additional

Published
2021
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21. Additional file 9 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 9.

Published
2020
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22. Additional file 7 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 7.

Published
2020
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23. Additional file 4 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 4.

Published
2020
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24. Additional file 2 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 2.

Published
2020
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25. Additional file 6 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 6.

Published
2020
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26. Additional file 5 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 5.

Published
2020
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27. Additional file 1 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 1.

Published
2020
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28. Additional file 3 of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Jain Holmes, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Subjects
Data_FILES
Abstract

Additional file 3.

Published
2020
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29. An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn, King, Kristelle, McLellan, Vicki, Sach, Tracey, Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O'Connor, Rory, Stevens, Judith, Phillips, Julie, Walker, Marion, Holmes, Jain, McEvitt, Christopher, Murray, John, Watkins, Caroline Leigh, Powers, Katie, Shone, Angela, Farrin, Amanda, Radford, Kathryn, King, Kristelle, McLellan, Vicki, Sach, Tracey, Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O'Connor, Rory, Stevens, Judith, Phillips, Julie, Walker, Marion, Holmes, Jain, McEvitt, Christopher, Murray, John, Watkins, Caroline Leigh, Powers, Katie, Shone, Angela, and Farrin, Amanda

Abstract

Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e., usual NHS rehabilitation) is more clinically and cost effective for supporting post-stroke RTW, than UC alone. Methods: 760 stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants’ homes or workplaces, outpatient/inpatient therapy settings, via telephone, email or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 hours/week). Secondary outcomes will include: mood; function; participation; health-related quality of life; confidence; intervention compliance; health and social care resource use; and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out. Discussion: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an earl

Published
2020

32. Is two better than one? Maximising follow-up of self-reported outcome measures for a stroke survivor population: Results from a study within a trial in the LoTS2Care feasibility study

Author

Moreau, Lauren, Holloway, Ivana, Ozer, Seline, Forster, Anne, Hulme, Claire, Hartley, Suzanne, and Farrin, Amanda

Abstract

Background: Improving outcome data collection rates is an essential part of managing clinical trials and ensures statistical power and generalisability of results are maintained. Studies within a trial (SWATs) provide a robust methodology to investigate the most efficient methods to maximise outcome follow-up.Methods: LoTS2Care, a feasibility cluster Randomised Controlled Trial, recruited 269 stroke survivors across 10 services, and incorporated a SWAT to evaluate the effect of questionnaire booklet format (one booklet or two) on follow-up rates for self-reported postal outcomes at 6 and 9 months post-recruitment. Available participants were individually randomised (1 : 1) by the Clinical Trials Research Unit and follow-up rates in the two groups were compared.Results: At 6 months post-recruitment, 254 participants were randomised: 126 to receive (125 posted) the single booklet; 128 to receive two booklets. By 9 months post-recruitment, 116 and 123 participants were still available in each group, respectively. For participants randomised to two booklets, return of at least one of the booklets was considered as ‘followed-up’. At 6 months, 114/125 (91.2%) participants sent the single booklet returned it, compared to 108/128 (84.4%) sent two (odds ratio (OR) 1.92, 95% confidence interval (CI) 0.88 to 4.19). By 9 months, 108/116 (93.1%) participants returned the single booklet, compared to 105/123 (85.4%) sent two (OR 2.31, 95% CI 0.97 to 5.55).Conclusions: The SWAT was an inexpensive, straightforward way to test how booklet format affected follow-up rates. Larger participant numbers would be required for conclusive results. These initial findings, however, suggest that including all outcome measures in a single booklet may maximise return rates, especially in trials with similar populations, such as those living with brain injury, cognitive or speech impairment or older people.

Published
2022
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33. An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn, primary, King, Kristelle, additional, McLellan, Vicki, additional, Sach, Tracey, additional, Brindle, Richard, additional, Holloway, Ivana, additional, Hartley, Suzanne, additional, Bowen, Audrey, additional, O'Connor, Rory, additional, Stevens, Judith, additional, Phillips, Julie, additional, Walker, Marion, additional, Holmes, Jain, additional, McEvitt, Christopher, additional, Murray, John, additional, Watkins, Caroline, additional, Powers, Katie, additional, Shone, Angela, additional, and Farrin, Amanda, additional

Published
2020
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34. Effectiveness of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: an open-cohort cluster randomised controlled trial

Author

Surr, Claire A., primary, Holloway, Ivana, additional, Walwyn, Rebecca E. A., additional, Griffiths, Alys W., additional, Meads, David, additional, Martin, Adam, additional, Kelley, Rachael, additional, Ballard, Clive, additional, Fossey, Jane, additional, Burnley, Natasha, additional, Chenoweth, Lynn, additional, Creese, Byron, additional, Downs, Murna, additional, Garrod, Lucy, additional, Graham, Elizabeth H., additional, Lilley-Kelly, Amanda, additional, McDermid, Joanne, additional, McLellan, Vicki, additional, Millard, Holly, additional, Perfect, Devon, additional, Robinson, Louise, additional, Robinson, Olivia, additional, Shoesmith, Emily, additional, Siddiqi, Najma, additional, Stokes, Graham, additional, Wallace, Daphne, additional, and Farrin, Amanda J., additional

Published
2020
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35. Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT

Author

Surr, Claire A, primary, Holloway, Ivana, additional, Walwyn, Rebecca EA, additional, Griffiths, Alys W, additional, Meads, David, additional, Kelley, Rachael, additional, Martin, Adam, additional, McLellan, Vicki, additional, Ballard, Clive, additional, Fossey, Jane, additional, Burnley, Natasha, additional, Chenoweth, Lynn, additional, Creese, Byron, additional, Downs, Murna, additional, Garrod, Lucy, additional, Graham, Elizabeth H, additional, Lilley-Kelley, Amanda, additional, McDermid, Joanne, additional, Millard, Holly, additional, Perfect, Devon, additional, Robinson, Louise, additional, Robinson, Olivia, additional, Shoesmith, Emily, additional, Siddiqi, Najma, additional, Stokes, Graham, additional, Wallace, Daphne, additional, and Farrin, Amanda J, additional

Published
2020
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36. Cohen-Mansfield Agitation Inventory Observational Tool

Author

Griffiths, Alys W., primary, Albertyn, Christopher P., additional, Burnley, Natasha L., additional, Creese, Byron, additional, Walwyn, Rebecca, additional, Holloway, Ivana, additional, Safarikova, Jana, additional, and Surr, Claire A., additional

Published
2020
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37. Additional file 1: of Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial

Author

Gunn, David, Fried, Ron, Lalani, Rabia, Farrin, Amanda, Holloway, Ivana, Morris, Tom, Olivier, Catherine, Kearns, Rachael, Corsetti, Maura, Scott, Mark, Farmer, Adam, Emmanuel, Anton, Whorwell, Peter, Yiannakou, Yan, Sanders, David, Mclaughlin, John, Kapur, Kapil, Eugenicos, Maria, Akbar, Ayesha, Trudgill, Nigel, Houghton, Lesley, Dinning, Phil, Ford, Alexander, Aziz, Qasim, and Spiller, Robin

Abstract

SPIRIT 2013 checklist. (DOCX 62 kb)

Published
2019
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38. Dopamine Augmented Rehabilitation in Stroke (DARS): a multicentre double-blind, randomised controlled trial of co-careldopa compared with placebo, in addition to routine NHS occupational and physical therapy, delivered early after stroke on functional recovery

Author

Ford, Gary A, Bhakta, Bipin B, Cozens, Alastair, Cundill, Bonnie, Hartley, Suzanne, Holloway, Ivana, Meads, David, Pearn, John, Ruddock, Sharon, Sackley, Catherine M, Saloniki, Eirini-Christina, Santorelli, Gillian, Walker, Marion, Farrin, Amanda, Ford, Gary A, Bhakta, Bipin B, Cozens, Alastair, Cundill, Bonnie, Hartley, Suzanne, Holloway, Ivana, Meads, David, Pearn, John, Ruddock, Sharon, Sackley, Catherine M, Saloniki, Eirini-Christina, Santorelli, Gillian, Walker, Marion, and Farrin, Amanda

Published
2019

39. Effectiveness of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: an open-cohort cluster randomised controlled trial.

Author

Surr, Claire A., Holloway, Ivana, Walwyn, Rebecca E. A., Griffiths, Alys W., Meads, David, Martin, Adam, Kelley, Rachael, Ballard, Clive, Fossey, Jane, Burnley, Natasha, Chenoweth, Lynn, Creese, Byron, Downs, Murna, Garrod, Lucy, Graham, Elizabeth H., Lilley-Kelly, Amanda, McDermid, Joanne, McLellan, Vicki, Millard, Holly, and Perfect, Devon

Subjects
CONFIDENCE intervals, MEDICAL care, PATIENTS, AGITATION (Psychology), MEDICAL care costs, RANDOMIZED controlled trials, COST effectiveness, DESCRIPTIVE statistics, QUALITY of life, STATISTICAL sampling
Abstract

Agitation is common and problematic in care home residents with dementia. This study investigated the (cost)effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation in this population. Pragmatic, cluster randomised controlled trial with cost-effectiveness analysis in 50 care homes, follow-up at 6 and 16 months and stratified randomisation to intervention (n = 31) and control (n = 19). Residents with dementia were recruited at baseline (n = 726) and 16 months (n = 261). Clusters were not blinded to allocation. Three DCM cycles were scheduled, delivered by two trained staff per home. Cycle one was supported by an external DCM expert. Agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16 months was the primary outcome. DCM was not superior to control on any outcomes (cross-sectional sample n = 675: 287 control, 388 intervention). The adjusted mean CMAI score difference was –2.11 points (95% CI –4.66 to 0.44, p = 0.104, adjusted ICC control = 0, intervention 0.001). Sensitivity analyses supported the primary analysis. Incremental cost per unit improvement in CMAI and QALYs (intervention vs control) on closed-cohort baseline recruited sample (n = 726, 418 intervention, 308 control) was £289 and £60,627 respectively. Loss to follow-up at 16 months in the original cohort was 312/726 (43·0%) mainly (87·2%) due to deaths. Intervention dose was low with only a quarter of homes completing more than one DCM cycle. No benefits of DCM were evidenced. Low intervention dose indicates standard care homes may be insufficiently resourced to implement DCM. Alternative models of implementation, or other approaches to reducing agitation should be considered. [ABSTRACT FROM AUTHOR]

Published
2021
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40. Additional file 1: of An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Author

Forster, Anne, Hartley, Suzanne, Barnard, Lorna, Ozer, Seline, Hardicre, Natasha, Crocker, Tom, Fletcher, Marie, Moreau, Lauren, Atkinson, Ross, Hulme, Claire, Holloway, Ivana, Schmitt, Laetitia, House, Allan, Hewison, Jenny, Richardson, Gillian, and Farrin, Amanda

Abstract

Detailed study objectives. This document includes further details on the study objectives. (DOCX 25Â kb)

Published
2018
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41. Additional file 3: of An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Author

Forster, Anne, Hartley, Suzanne, Barnard, Lorna, Ozer, Seline, Hardicre, Natasha, Crocker, Tom, Fletcher, Marie, Moreau, Lauren, Atkinson, Ross, Hulme, Claire, Holloway, Ivana, Schmitt, Laetitia, House, Allan, Hewison, Jenny, Richardson, Gillian, and Farrin, Amanda

Subjects
social sciences, human activities, humanities
Abstract

LoTS2Care trial information and consent documentation. This document includes all information sheets and consent forms provided to the stroke survivors and carers involved in the trial. (PDF 340Â kb)

Published
2018
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42. Additional file 2: of An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

Author

Forster, Anne, Hartley, Suzanne, Barnard, Lorna, Ozer, Seline, Hardicre, Natasha, Crocker, Tom, Fletcher, Marie, Moreau, Lauren, Atkinson, Ross, Hulme, Claire, Holloway, Ivana, Schmitt, Laetitia, House, Allan, Hewison, Jenny, Richardson, Gillian, and Farrin, Amanda

Abstract

SPIRIT checklist. This document includes the completed SPIRIT checklist. (DOC 123Â kb)

Published
2018
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44. Dopamine Augmented Rehabilitation in Stroke (DARS): a multicentre double-blind, randomised controlled trial of co-careldopa compared with placebo, in addition to routine NHS occupational and physical therapy, delivered early after stroke on functional recovery

Author

Ford, Gary A, primary, Bhakta, Bipin B, additional, Cozens, Alastair, additional, Cundill, Bonnie, additional, Hartley, Suzanne, additional, Holloway, Ivana, additional, Meads, David, additional, Pearn, John, additional, Ruddock, Sharon, additional, Sackley, Catherine M, additional, Saloniki, Eirini-Christina, additional, Santorelli, Gillian, additional, Walker, Marion F, additional, and Farrin, Amanda J, additional

Published
2019
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46. A protocol for a systematic review of process evaluations of interventions investigating sedentary behaviour in adults

Author

Corepal, Rekesh, Hall, Jessica, Birch, Karen, Carter, Gill, English, Coralie, Farrin, Amanda J, Fitzsimons, Claire, Forster, Anne, Hall, Jennifer, Holloway, Ivana, Lawton, Rebecca, Mead, Gillian, Morton, Sarah, Patel, Anita, and Clarke, David

Subjects
Gerontology, Process (engineering), Psychological intervention, Health Promotion, Sitting, Metabolic equivalent, 03 medical and health sciences, sedentary, 0302 clinical medicine, systematic review, Intervention (counseling), sedentary behaviour, adults, Protocol, Humans, Medicine, protocol, 030212 general & internal medicine, Exercise, Protocol (science), business.industry, Process Assessment, Health Care, 030229 sport sciences, General Medicine, process evaluation, Data extraction, Research Design, Public Health, Sedentary Behavior, business, Lying, Systematic Reviews as Topic
Abstract

IntroductionSedentary behaviour is defined as any waking behaviour characterised by low energy expenditure ≤1.5 Metabolic Equivalents (METs) while in a sitting, lying or reclining posture. The expanding evidence base suggests that sedentary behaviour may have a detrimental effect on health, wellbeing, and is associated with an increased risk of all-cause mortality. We aim to review process evaluations of randomised controlled trials (RCTs) which included a measure of sedentary behaviour in adults in order to develop an understanding of intervention content, mechanisms of impact, implementation and delivery approaches and contexts, in which interventions were reported to be effective or effective. A secondary aim is to summarise participants, family, and staff experiences of such interventions.Methods and analysis: Ten electronic databases and reference lists from previous similar reviews will be searched. Eligible studies will be process evaluations of RCTs that measure sedentary behaviour as a primary or secondary outcome in adults. Interventions delivered in schools, colleges, universities or workplaces will be excluded as this review is part of a programme to develop a community-based intervention to reduce sedentary behaviour in stroke survivors. Two reviewers will perform study selection, data extraction, and quality assessment. Disagreements between reviewers will be resolved by a third reviewer. Process evaluation data to be extracted include: the aims and methods used in the process evaluation; implementation data; mechanisms of impact; contextual factors; participant, family, and staff experiences of the interventions. Trial data to be extracted include: trial design; participant numbers; duration and content of the intervention; outcome results (if necessary, this information will be sought outside of the process evaluation paper e.g. the trial paper)_A narrative approach will be used to synthesise and report qualitative and quantitative data. Reporting of the review will be informed by Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidance. Ethics and dissemination:Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.Protocol registration number: CRD42018087403

Published
2019

47. Validation of the Cohen-Mansfield Agitation Inventory Observational (CMAI-O) tool.

Author

Griffiths, Alys W., Albertyn, Christopher P., Burnley, Natasha L., Creese, Byron, Walwyn, Rebecca, Holloway, Ivana, Safarikova, Jana, and Surr, Claire A.

Abstract

Objectives: Behaviours associated with agitation are common in people living with dementia. The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale widely used to assess agitation completed by a proxy (family carer or staff member). However, proxy informants introduce possible reporting bias when blinding to the treatment arm is not possible, and potential accuracy issues due to irregular contact between the proxy and the person with dementia over the reporting period. An observational measure completed by a blinded researcher may address these issues, but no agitation measures with comparable items exist.Design: Development and validation of an observational version of the CMAI (CMAI-O), to assess its validity as an alternative or complementary measure of agitation.Setting: Fifty care homes in England.Participants: Residents (N = 726) with dementia.Measurements: Two observational measures (CMAI-O and PAS) were completed by an independent researcher. Measures of agitation, functional status, and neuropsychiatric symptoms were completed with staff proxies.Results: The CMAI-O showed adequate internal consistency (α = .61), criterion validity with the PAS (r = .79, p = < .001), incremental validity in predicting quality of life beyond the Functional Assessment Staging of Alzheimer's disease (β = 1.83, p < .001 at baseline) and discriminant validity from the Neuropsychiatric Inventory Apathy subscale (r = .004, p = .902).Conclusions: The CMAI-O is a promising research tool for independently measuring agitation in people with dementia in care homes. Its use alongside the CMAI could provide a more robust understanding of agitation amongst residents with dementia. [ABSTRACT FROM AUTHOR]

Published
2020
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48. O3‐08‐06: RESULTS OF A PRAGMATIC, CLUSTER RANDOMISED, CONTROLLED TRIAL OF THE EFFECTIVENESS AND COST‐EFFECTIVENESS OF DEMENTIA CARE MAPPING (DCM) IN UK CARE HOMES (DCM EPIC TRIAL)

Author

Surr, Claire, primary, Holloway, Ivana, additional, Walwyn, Rebecca EA., additional, Griffiths, Alys W., additional, Meads, David, additional, Kelley, Rachael, additional, Martin, Adam, additional, McLellan, Vicki, additional, Ballard, Clive, additional, Fossey, Jane, additional, Burnley, Natasha, additional, Chenoweth, Lynn, additional, Creese, Byron, additional, Downs, Murna, additional, Garrod, Lucy, additional, Graham, Elizabeth H., additional, Lilley-Kelley, Amanda, additional, McDermid, Joanne, additional, Millard, Holly, additional, Perfect, Devon, additional, Robinson, Louise, additional, Robinson, Olivia, additional, Shoesmith, Emily, additional, Siddiqi, Najma, additional, Stokes, Graham, additional, Wallace, Daphne, additional, and Farrin, Amanda, additional

Published
2018
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49. The Clinical and Cost Effectiveness of Dementia Care Mapping (DCM™) to Reduce Agitation in Care Home Residents with Dementia: Results of the DCM™ EPIC Cluster Randomised Controlled Trial

Author

Surr, Claire A, primary, Holloway, Ivana, additional, Walwyn, Rebecca EA, additional, Griffiths, Alys W, additional, Meads, David, additional, Kelley, Rachael, additional, Martin, Adam, additional, Ballard, Clive, additional, Fossey, Jane, additional, Burnley, Natasha, additional, Chenoweth, Lynn, additional, Creese, Byron, additional, Downs, Murna, additional, Garrod, Lucy, additional, Graham, Elizabeth H, additional, Lilley-Kelly, Amanda, additional, McDermid, Joanne, additional, McLellan, Vicki, additional, Millard, Holly, additional, Perfect, Devon, additional, Robinson, Louise, additional, Robinson, Olivia, additional, Shoesmith, Emily, additional, Siddiqi, Najma, additional, Stokes, Graham, additional, Wallace, Daphne, additional, and Farrin, Amanda J, additional

Published
2018
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50. Additional file 1: of Evaluating the effectiveness and cost-effectiveness of Dementia Care Mappingâ ˘ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial

Author

Surr, Claire, Walwyn, Rebecca, Lilley-Kelly, Amanda, Cicero, Robert, Meads, David, Ballard, Clive, Burton, Kayleigh, Chenoweth, Lynn, Corbett, Anne, Creese, Byron, Murna Downs, Farrin, Amanda, Fossey, Jane, Garrod, Lucy, Graham, Elizabeth, Griffiths, Alys, Holloway, Ivana, Jones, Sharon, Baber Malik, Siddiqi, Najma, Robinson, Louise, Stokes, Graham, and Wallace, Daphne

Subjects
body regions, nervous system, fungi
Abstract

Schedule of enrolment, interventions and assessments. (PDF 122 kb)

Published
2016
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